Trial Outcomes & Findings for Ketorolac Effects on Post-operative Pain and Bone Healing (NCT NCT01133639)
NCT ID: NCT01133639
Last Updated: 2019-08-21
Results Overview
18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
TERMINATED
NA
18 participants
Post-Operative Day 2
2019-08-21
Participant Flow
18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Participant milestones
| Measure |
Placebo
Placebo plus standard of care
Placebo: Placebo plus standard of care
|
Ketorolac
30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care
Ketorolac: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketorolac Effects on Post-operative Pain and Bone Healing
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Post-Operative Day 2Population: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Radiographic assessment by a blinded board certified radiologist
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 3 monthsPopulation: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Functional Recovery Index
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekPopulation: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Comparison of adverse events between the two study arms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekPopulation: 18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Comparison of quantity of narcotic medication utilized within the two study arms
Outcome measures
Outcome data not reported
Adverse Events
Placebo or Ketorolac
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place